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COMPLETED Phase 3

Open Label Extension Study of PREOS

NCT00172133 · View on ClinicalTrials.gov ↗

Study Summary

This is an Open Label Extension Study (OLES) for patients who participated in the 18 month double-blind, placebo-controlled, Phase III trial (Protocol ALX1 11 93001 the TOP Study) studying the effect of ALX1-11, recombinant human parathyroid hormone, rhPTH(1-84), on vertebral fracture incidence. The primary objective of this study is to evaluate the safety of continued dosing with ALX1-11, up to a maximum of 24 months, in postmenopausal osteoporotic women who participated in Protocol ALX1 11 93001.

Conditions Studied

Interventions

  • DRUG ALX1-11 (drug)

Study Locations (20)

California

  • 'Osteoporosis Medical Center — Beverly Hills
  • 'East Bay Clinical Trial Center — Concord
  • 'Loma Linda Osteoporosis Research Center — Loma Linda
  • Foundation for Osteoporosis Research — Oakland
  • 'Desert Medical Advances — Palm Desert
  • 'VA Palo Alto Health Care System — Palo Alto
  • 'Boling Clinical Trials — Rancho Cucamonga
  • 'S.D. Arthritis & Osteoporosis Medical Clinic — San Diego
  • 'Radiant Research - San Diego — San Diego
  • 'San Francisco General Hospital — San Francisco

Florida

  • 'RASF - Clinical Research Center — Boca Raton
  • 'The Center for Diabetes and Endocrine Care — Hollywood
  • 'Florida Wellcare Alliance — Inverness
  • 'Renstar Medical Group — Ocala
  • 'The Arthritis Center — Palm Harbor

Alabama

  • 'The University of Alabama at Birmingham — Birmingham
  • 'Rheumatology Associates of North Alabama — Huntsville

Arizona

  • 'Radiant Research - Phoenix North — Phoenix

Colorado

  • 'Longmont Medical Research Network — Longmont

Connecticut

  • 'Northeast Clinical Research, LLC — Hamden

Trial Details

FieldValue
Enrollment Target 1,683 participants
Start Date 2001-10-16
Est. Completion 2005-04-13
Phase Phase 3

Sponsor

Shire

56 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00172133

The ClinicalTrials.gov registry entry for NCT00172133 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,683 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 56 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Osteoporosis appearing as the primary indexed condition, and to 1 intervention — of which ALX1-11 (drug) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00172133 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00172133 about?

NCT00172133 is a clinical study titled "Open Label Extension Study of PREOS". This is an Open Label Extension Study (OLES) for patients who participated in the 18 month double-blind, placebo-controlled, Phase III trial (Protocol ALX1 11 93001 the TOP Study) studying the effect of ALX1-11, recombinant human parathyroid hormone, rhPTH(1-84), on vertebral fracture incidence. The...

What is the current status of trial NCT00172133?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,683 participants. The study started on 2001-10-16. Estimated completion is 2005-04-13.

What conditions does trial NCT00172133 study?

This clinical trial studies the following conditions: Osteoporosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00172133?

The interventions under investigation include: ALX1-11 (drug) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00172133?

This trial is sponsored by Shire, which has 56 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00172133 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial